Prospective Multi-Center Study to Identify Barriers to Cellular Therapies in Patients With Plasma Cell Disorders PROACT PCD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 15
- 主要终点
- Rates of referral
研究概览
简要总结
This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR autologous T-cell therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Multiple Myeloma after January 1,
- •Karnofsky Performance Status > 70%
- •≥ 2 lines of prior therapy
- •Anticipated to start new a line of therapy for RRMM within the next 12 months
- •Age 18-80 years of age.
- •English or Spanish speaking.
- •Willing to provide informed consent
- •Willing to perform study procedures.
- •Physician Investigator
- •Be a Co-Investigator
- •Agree to comply with study procedures
排除标准
- •Active CNS disease
- •Patients who already have a definitive plan are to be excluded
研究组 & 干预措施
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
干预措施: Distress Thermometer (Behavioral)
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
干预措施: FACT-BMT (Behavioral)
Physician Group 1: Primary Myeloma Therapy
Physicians in this group refer for cellular therapy but do not perform the infusions.
干预措施: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM (Other)
Physician Group 2: CAR Enabled
These physicians can order and infuse CAR T cells but not stem cells.
干预措施: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM (Other)
Physician Group 3: HCT and CAR Enabled
These physicians can order and infuse stem cells and CAR T cells
Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
干预措施: Hospital Anxiety and Depression Scale (Behavioral)
Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
干预措施: Duke-UNC Functional Social Support Questionnaire (Behavioral)
Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
干预措施: Distress Thermometer (Behavioral)
Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
干预措施: FACT-BMT (Behavioral)
Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
干预措施: Psychosocial Assessments of Candidates for Transplantation (Behavioral)
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
干预措施: Hospital Anxiety and Depression Scale (Behavioral)
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
干预措施: Duke-UNC Functional Social Support Questionnaire (Behavioral)
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
干预措施: Psychosocial Assessments of Candidates for Transplantation (Behavioral)
结局指标
主要结局
Rates of referral
时间窗: Up to 76 months
To prospectively estimate the rates of referral and utilization of salvage autologous hematopoietic cell transplantation (HCT) and B cell maturation antigen (BCMA) Targeted Chimeric Antigen Receptor (CAR) autologous T cell therapies among patients with RRMM.
次要结局
未报告次要终点